Apply📍 United States
🧭 Full-Time
💸 135000.0 - 160000.0 USD per year
🔍 Digital health and specialty biopharmaceuticals
- 10+ years in a quality assurance/quality management role at a software company dealing with healthcare data.
- Experience in establishing a Quality Management System including SOPs and training.
- Prior CAPA experience with incident reviews and implementing preventive actions.
- Proven ability to collaborate between professional services and software teams for incident reporting.
- Lean/Six Sigma training is strongly preferred.
- Establish and maintain a Quality Management System and QA Model.
- Define a standard QA model to ensure independent QC and documentation for new or updated deliverables.
- Create detailed test scripts for different testing scenarios.
- Establish QC process guidelines including hand-offs and documentation.
- Manage incidents and CAPA processes, tracking issues in productions.
- Monitor production support tickets to identify trends and improve performance.
- Review incidents with CX and Dev teams to document root causes.
- Suggest preventive measures and educate internal teams on actions.
- Prepare external communications regarding root causes and resolutions.
- Facilitate hand-offs between CX functional groups.
- Perform implementation audits against customer contracts.
- Attend project implementation retrospectives to implement learnings.
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Posted about 1 month ago
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